Anti-Obesity Agents Drug Class Prior Authorization Protocol

Transcription

1 Anti-Obesity Agents Drug Class Prior Authorization Protocol Line of Business: Medicaid P & T Approval Date: February 21, 2018 Effective Date: March 1, 2018 This policy has been developed through review of medical literature, consideration of medical necessity, generally accepted medical practice standards, and approved by the IEHP Pharmacy and Therapeutics Subcommittee. Drug Requiring Prior Authorization Review: Adipex-P, Fastin (phentermine), Alli (orlistat, over-the-counter), Belviq, Belviq XR (lorcaserin), Bontril, Bontril PDM (phendimetrazine), Contrave ER (naltrexone HCl, bupropion HCl), Didrex (benzphetamine), Qsymia (phentermine, topiramate), Saxenda (liraglutide recombinant), Tenuate (diethylpropion), Tenuate Dospan (diethylpropion ER), Xenical (orlistat) Formulary Alternative: None Criteria: A. Drug: phentermine (Adipex-P) Criteria: Must meet 1 of the following requirements: a. BMI greater than or equal to 30 kilograms per meter squared. b. BMI great than or equal to 27 kilograms per meter squared with a comorbidity. A comorbidity is defined but not limited to 1 of the i. Diabetes Mellitus Type II ii. Coronary Heart Disease iii. Hyperlipidemia iv. Hypertension v. Sleep Apnea

2 Quantity Limit: 30 tablets per month (30 days) B. Drug: Alli Criteria: Must meet 1 of the following requirements: a. BMI greater than or equal to 30 kilograms per meter squared. b. BMI great than or equal to 27 kilograms per meter squared with a comorbidity. A comorbidity is defined but not limited to 1 of the i. Diabetes Mellitus Type II ii. Coronary Heart Disease iii. Hyperlipidemia iv. Hypertension v. Sleep Apnea Quantity Limit: 90 capsules per month (30 days) C. Drug: Belviq, Belviq XR a. Failure or clinically significant adverse effects to all of the

3 comorbidity. A comorbidity is defined but not limited to 1 of the Coronary Heart Disease Quantity Limit: a. Belviq: 60 tablets per month (30 days) b. Bleviq XR: 30 tablets per month (30 days) D. Drug: Bontril, Bontril Slow Release a. Failure or clinically significant adverse effects to all of the

4 Coronary Heart Disease Quantity Limit: a. Bontril: 90 capsules per month (30 days) b. Bontril Slow Release: 30 capsules per month (30 days) E. Drug: Contrave ER a. Failure or clinically significant adverse effects to all of the Coronary Heart Disease Quantity Limit: 120 tablets per month (30 days)

5 F. Drug: Didrex a. Failure or clinically significant adverse effects to all of the Coronary Heart Disease Quantity Limit: 30 tablets per month (30 days)

6 G. Drug: Qysmia a. Failure or clinically significant adverse effects to all of the Coronary Heart Disease Quantity Limit: 30 capsules per month (30 days) H. Drug: Saxenda (liraglutide recombinant) a. Failure or clinically significant adverse effects to all of the

7 ii. BMI greater than or equal to 27 kilograms per meter squared with Coronary Heart Disease Quantity Limit: 1 pen per month (30 days) I. Drug: diethylpropion (Tenuate), diethylpropion ER (Tenuate Dospan) Criteria: Must meet 1 of the following requirements: a. BMI greater than or equal to 30 kilograms per meter squared. b. BMI greater than or equal to 27 kilograms per meter squared with comorbidity. A comorbidity is defined but not limited to one of the i. Diabetes Mellitus Type II ii. Coronary Heart Disease iii. Hyperlipidemia iv. Hypertension v. Sleep Apnea Quantity Limit: a. Tenuate: 90 tablets per month (30 days) b. Tenuate Dospan: 30 tablets per month (30 days)

8 J. Drug: orlistat (Xenical) a. Failure or clinically significant adverse effects to all of the Diabetes mellitus type II Coronary heart disease Sleep apnea Quantity Limit: 1 capsule per day

9 Clinical Justification: 1. FDA-approved weight loss medications may be part of comprehensive weight management program to enhance weight loss in overweight and obese adults. 2. Weight loss medications approved by FDA for long-term use may be useful as adjunct to diet, physical activity, and behavior therapy for patients with body mass index (BMI) 30 kg/m2 without concomitant obesity-related comorbidity, or BMI 27 kg/m2 with concomitant obesity-related comorbidity (e.g. diabetes, hypertension, or dyslipidemia). 3. Orlistat, phentermine, diethylpropion, lorcaserin and bupropion/naltrexone have comparable efficacy (weight loss ranged from -6.5kg to -5.3kg). 4. Orlistat has relatively more well-established longterm safety data up to four years. 5. Sympathomimetic drugs including phentermine, diethylpropion, benzphetamine, and phendimetrazine, are contraindicated in patients with coronary heart disease, uncontrolled hypertension, hyperthyroidism, or in patients with a history of drug abuse. 6. Methamphetamine (Desoxyn) is generally not recommended in obesity, due to high potential for abuse and addiction with limited supportive data. 7. Benzphetamine (Didrex) and phendimetrazine (Bontril) are CIII medications with high potential for abuse and addiction. 8. People typically lose 5 to 10 pounds in a year with anti-obesity medications AHA/ACC/TOS Guideline for the Management of Overweight and Obesity in Adults: Weight loss treatment is indicated for 1) obese individuals (BMI 30) and 2) overweight individuals (BMI ) with 1 indicators of increased cardiovascular risk (e.g. diabetes, prediabetes, hypertension, dyslipidemia, elevated waist circumference) or other obesity-related comorbidities. All patients for whom weight loss is recommended should be offered or referred for comprehensive lifestyle intervention, preferably with a trained interventionist or nutrition professional, which include: 1) prescription of a moderately reduced-calorie diet, 2) a program of increased physical activity, and 3) the use of behavioral strategies to facilitate adherence to diet and activity recommendation. The Expert Panel did not review comprehensive evidence for pharmacotherapy for weight loss. On the basis of expert opinion, the panelists recommend that for individuals with BMI 30 or BMI 27 with 1 obesity-associated comorbid condition(s) who are motivated to lose weight, pharmacotherapy can be considered as an adjunct to comprehensive lifestyle intervention to help achieve targeted weight loss and health goals. Medications should be FDA approved, and potential benefits should be weighed against the potential risks. The rationale for use of medications is to help patients to adhere to a lower-calorie diet more consistently to achieve sufficient weight loss and health

10 References: improvements when combined with increased physical activity, as an adjunct to lifestyle interventions. 1. The Practical Guide: Identification, Evaluation, and Treatment of Overweight and Obesity in Adults. National Heart Lung and Blood Institute (NHLBI) Obesity Education Initiative. NIH Publication No October American Dietetic Association (ADA) position statement on weight management. J Am Diet Assoc 2009 Feb;109(2): Product information for Didrex. Pfizer. New York, NY August A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Obesity Society. Journal of the American College of Cardiology, Vol.63, No.25, Package insert and label information for Bontril. Apotheca, Inc. Augest The Pharmacological Management of Obesity: An Endocrine Society Clinical Practice Guideline. J Clin Endrcrinol Metab, February 2015, 100(2): AHA/ACC/TOC guideline for the management of overweight and obesity in adults. Circulation. June 2014: 129(25 suppl 2):S Change Control Date Change 02/21/2018 Removed requirement for weight management class Removed Suprenza (no longer available)